Trial reportTrials2012
Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: study protocol for a randomized controlled trial.
Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.
- Non-pharmacological interventions for sleep disturbances in people with dementia.The Cochrane database of systematic reviews · 2023Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany older people with neuropsychiatric disorders such as Alzheimer's disease and frontotemporal dementia suffer from sleeping problems and often show nocturnal restlessness. Professionals and informal carers face considerable problems in solving these problems. Attempts to diminish these problems with medication in a safe and responsible manner have proven hardly effective or not effective at all. Therefore, nowadays the focus lies more on non-pharmacological solutions, for example by influencing environmental factors. There are indications that treatment with low-frequency acoustic vibrations, that is Physio Acoustic Sound (PAS) therapy, has a positive effect on sleeping problems. Therefore we study the effectiveness of PAS therapy in demented patients with nocturnal restlessness.
methodsIn a randomized clinical trial, 66 nursing home patients will be divided into two groups: an intervention group and a control group. For both groups nocturnal restlessness will be measured with actiwatches during a period of six weeks. In addition, a sleep diary will be filled in.For the intervention group the baseline will be assessed, in the first two weeks, reflecting the existing situation regarding nocturnal restlessness. In the next two weeks, this group will sleep on a bed identical to their own, but with a mattress containing an in-built PAS device. As soon as the patient is lying in bed, the computer programme inducing the vibrations will be switched on for the duration of 30 min. In the last two weeks, the wash-out period, the measurements of the intervention group are continued, without the PAS intervention.During the total study period, other relevant data of all the implied patients will be recorded systematically and continuously, for example patient characteristics (data from patient files), the type and seriousness of the dementia, occurrence of neuropsychiatric symptoms during the research period, and the occurrence of intermittent co-morbidity. DISCUSSION: If PAS therapy turns out to be effective, it can be of added value to the treatment of nocturnal restlessness in demented patients. Non-pharmacological PAS therapy is not only safe and patient-friendly, but it can also be widely used in a simple and relatively inexpensive way, both in institutions such as nursing homes and residential homes for the elderly, and at home. Ultimately, this may lead to a decrease in the frequent and still common use of psychotropic drugs. In addition, care needs of demented patients also may decrease as well as the number of preventable admissions to care institutions.
trial registrationNetherlands Trial Register (NTR): NTR3242.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.